New Product Transfer Scientist I (Must Protocol Writing, PCR, NGS, Molecular Biology Exp)

Job Description

With supervision, participates in new product teams responsible for the development, scale up, validation and transfer of production processes to Operations.

Works on problems where analysis of situations or data requires an evaluation of various factors.

Affords assistance in improving process efficiency and product quality. May determine methods and procedures on new assignments, and may provide guidance to other lower level associates.

• Work in new product transfer of single cell Multiomics products.
• May participate as a member of the operation team and support core team member
• Assists in the successful transfer of products and processes into manufacturing following the Global Product Development System
• Develops, scales up and sets up the manufacturing processes.
• Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP
• Supports validation activities.
• Supports senior BPEs to analyze and solve problems in Production and Quality Control.
• Supports in the designing, writing and executing of protocols, reports, data analysis and other quality documents.
• Makes recommendations for process improvements.
• Trains manufacturing associates in new processes and procedures

Minimum Qualifications

• Requires a minimum of a Bachelor’s degree in biological sciences and a minimum of 3 years of hands-on laboratory experience in a reagent process development or reagent manufacturing environment or Master’s degree in related field.
• A working knowledge of molecular biology techniques like PCR, NGS is required.
• A minimum of 1 year experience in a FDA or ISO/GMP regulated production environment.